The OGD updated its usual February statistical report late yesterday (April 18, 2022) to complete the month’s reporting. To start out with a bit of a startling number, February saw nine ANDAs issued refuse‑to‑receive (RTR) letters. This is triple the number in any month this FY (only three RTRs were reported in each of the […]
Today, the FDA published the final guidance titled “Bioavailability Studies Submitted in NDAs or INDs — General Considerations” (here). The final guidance comes after the FDA incorporated comments that it received on the draft of the same name issued on February 26, 2019. That 2019 draft guidance replaced the March 2014 guidance titled “Bioavailability and Bioequivalence Studies […]
The 505(b)(2) application is really a hybrid of a New Drug Application (NDA) approved under Section 505C of the FFDCA Act (the Act) and an Abbreviated New Drug Application (ANDA) which is approved under Section 505(j) of the Act. The (b)(2) pathway was a creation born out of the Hatch-Waxman Act of 1984. It permits […]
March ANDA full‑approval actions (reported thus far) sit at sixty‑three, the second highest total this fiscal year (FY), eclipsed only by the sixty‑seven full‑approval actions in November. That’s the good news! The OGD only issued four tentative‑approval (TA) actions in March, the lowest number this FY (the previous range was eight in November to twenty‑two […]
The ICH has developed a draft of the new ICH Quality Guideline, ICH Q14, Analytical Procedure Development, and revision of ICH Q2(R2), Guideline on Validation of Analytical Procedures, both endorsed on March 22, 2022 for public consultation. The draft, along with other ICH guidances on validation and analytical procedures, can be found here. The draft revision of […]
The theme for the PDA annual meeting this year is “Agility in the New Normal.” The plenary address kicked off the meeting with an interesting presentation by Dr. Jeffrey Baker, Senior Fellow, National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), titled “Pandemic Response, Regulatory Rubric, and the Nature of Rubber Bands.” He spoke about the intrinsic […]
Ever since I was an expert witness in one of the very first “pay-for-delay” cases back in the day, I have never understood how an arrangement that permits a drug to come to market well in advance of the expiration of a patent (and I am not talking about a weak patent that maybe never […]
After almost three months of calendar year 2022, the OGD is reporting twenty‑two first-time generic approvals. That seem like a whole lot but remember that if there are multiple first‑to‑file or first‑to‑approve ANDAs (which can sometime happen) for the same drug product, all of those that receive final approval on the same day are counted […]
In an announcement today, the FDA reminded manufacturers of alcohol-based hand sanitizers that they can no longer distribute products made under the temporary policy, which was withdrawn on December 31, 2021 and gave manufacturers until March 31, 2022 to comply (see the announcement here). The Agency notes that distribution from manufacturers to all outlets, which […]
First of all, Happy St. Patrick’s Day! The luck of the Irish prevailed last night as, one minute after midnight on March 17th, the Notre Dame Fighting Irish basketball team won its NCAA play-in game in double overtime for a chance to play #6 seed Alabama on Friday. I guess I have some luck too […]
